Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203339
Company: LUPIN LTD
Company: LUPIN LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | BX | No | No |
AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | BX | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/20/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/15/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
04/21/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMABELZ
There are no Therapeutic Equivalents.